The Navigo system has been approved by the CE. The 3D tracking system is approved by the FDA for medical use and is classified as Type CF which is the most stringent classification, being required for those applications where the applied part is in direct conductive contact with the heart or other applications as considered necessary. The 3D tracking system is also part of an approved Helsinki trial in Bnei-zion hospital (monitoring of the birth progress, trial initiated by Dr. Yoav Paltieli) Adverse effects are not expected according to the accumulated experience with the 3D tracking system. Similarly, the Navigo™ system is not expected to add to the procedure any pain or discomfort to the patients.